Devices, Systems, and Methods Related to Analyte Monitoring and Management

ABSTRACT

Analyte monitoring devices, systems, and methods are provided that relate to: enabling different application features on a data processing device for analyte monitoring devices with different analyte monitoring features; programming analyte monitoring devices in advance; personalizing an analyte monitoring device; graphically representing a remaining insulin level in a user body; and graphically representing analyte measurement related data for on-demand readings; protecting access to feature of an analyte monitoring device.

PRIORITY

This application claims the benefit of priority to U.S. ProvisionalPatent Application No. 61/327,023, filed Apr. 22, 2010, which is herebyincorporated by reference.

BACKGROUND

Analyte monitoring devices have been used as medical diagnostic devicesto determine a level of analyte from a sample. One common application isblood glucose measurements for diabetics. The diabetic typically prickshis or her finger using a lancet. A droplet of exposed blood is appliedto a sensor on a test strip which is placed in the analyte monitoringdevice (in this case a glucose meter). A reading appears on a display ofthe measuring device indicating the blood glucose level of the diabetic.Analyte monitoring devices may be used to receive analyte measurementreadings over a period of time for purposes of monitoring a patient'sstatus or progress.

BRIEF DESCRIPTION OF THE FIGURES

The subject matter of the present disclosure is best understood from thefollowing detailed description when read in conjunction with theaccompanying drawings. It is emphasized that, according to commonpractice, the various features of the drawings are not to-scale. On thecontrary, the dimensions of the various features are arbitrarilyexpanded or reduced for clarity. Included are the following:

FIGS. 1A-1C illustrates a block diagram representing an overview of auser interface flow for an analyte monitoring device, according to someembodiments

FIG. 2 illustrates a home screen, according to certain embodiments.

FIG. 3A illustrates a flowchart for personalizing an analyte monitoringdevice, according to certain embodiments.

FIG. 3B illustrates an example block diagram for a method that isperformed when the instruction are executed by the processor, accordingto certain embodiments.

FIGS. 4A-4B illustrate a remote data processing device having RDsoftware that enables it to operate with one type of analyte monitoringdevice but not another type of analyte monitoring device.

FIG. 4C illustrates a remote data processing device receiving RDsoftware from an analyte monitoring device that enables the dataprocessing device to operate with multiple types of analyte monitoringdevices, according to certain embodiments.

FIG. 4D illustrates device 455 operably connected to any one of theanalyte monitoring devices 401, 402, and 455, according to certainembodiments.

FIG. 4E illustrates a block diagram for a method of enabling differentapplication features on a data processing device for analyte monitoringdevices with different analyte monitoring features, according to certainembodiments.

FIG. 5 illustrates a block diagram of a system including an analytemonitoring device and remote data processing device, according to someembodiments.

FIG. 6 illustrates an analyte monitoring device used with a remotesensor, according to some embodiments.

FIG. 7A illustrates a Snapshot report for a specific time frame (e.g., atwo week period as shown), according to certain embodiments.

FIG. 7B illustrates a Logbook report, according to certain embodiments.

FIG. 7C illustrates a Daily Statistics Report, according to certainembodiments.

FIG. 7D illustrates a Meal Event Averages report, according to certainembodiments.

FIG. 7E illustrates a Modal Day report, according to certainembodiments.

FIG. 7F illustrates a Meter Settings report, according to certainembodiments.

FIG. 8 illustrates an example user interface for personalizing ananalyte monitoring device with a remote data processing device,according to certain embodiments.

FIG. 9 illustrates an analyte monitoring device configured with apersonalized background image, according to certain embodiments.

FIGS. 10A-10B illustrate an example graphical user interface elementthat functions as a fill-level indicator, according to some embodiments.

FIGS. 11A-11B illustrate an example graphical user interface elementrepresenting insulin remaining in a body, according to some embodiments.

FIG. 12A-12B illustrate a graphical element representing insulin in thebody, according to certain embodiments.

FIG. 13A illustrates a plot for continuous glucose measurements.

FIG. 13B illustrates a plot of magnitudes for on-demand measurements forthe same glucose pattern.

FIG. 13C illustrates a plot of magnitudes and rate-of-change data,according to certain embodiments.

FIG. 14 illustrates a plot using forward and backward prediction errorsto provide a line between plots, according to certain embodiments.

DETAILED DESCRIPTION

Before the subject matter of the present disclosure is described, it isto be understood that the present disclosure is not limited toparticular aspects described, as such may, of course, vary. It is alsoto be understood that the terminology used herein is for the purpose ofdescribing particular aspects only, and is not intended to be limiting,since the scope of the present disclosure will be limited only by theappended claims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the present disclosure. The upper and lower limits of thesesmaller ranges may independently be included or excluded in the range,and each range where either, neither or both limits are included in thesmaller ranges is also encompassed within the present disclosure,subject to any specifically excluded limit in the stated range. Wherethe stated range includes one or both of the limits, ranges excludingeither or both of those included limits are also included in the presentdisclosure.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this present disclosure belongs. Although any methodsand materials similar or equivalent to those described herein can beused in the practice or testing of the subject matter of the presentdisclosure, some potential and preferred methods and materials are nowdescribed. All publications mentioned herein are incorporated herein byreference to disclose and describe the methods and/or materials inconnection with which the publications are cited. It is understood thatthe present disclosure supercedes any disclosure of an incorporatedpublication to the extent there is a contradiction.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “afeature” includes a plurality of such features and reference to “thefeature” includes reference to one or more features and equivalentsthereof known to those skilled in the art, and so forth.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present disclosure isnot entitled to antedate such publication. Further, the dates ofpublication provided may be different from the actual publication dateswhich may need to be independently confirmed.

User Interface for the Analyte Monitoring Device

In the present disclosure, various block diagrams, flowcharts, andgraphical user interfaces (GUI) associated with an analyte monitoringdevice are discussed and illustrated. It should be understood that thespecific embodiments discussed and shown are exemplary and that otherembodiments may be implemented without compromising the underlyingprinciples in the present disclosure. For example, all features shown inthe exemplary embodiments are not necessarily required and may becombined, deleted, etc., in some situations without compromising theunderlying principles in the present disclosure.

In some aspects, the analyte monitoring device stores software programsand applications in, for example, Flash memory, or other non-volatilememory. The software programs and applications that are installed andstored in memory in the analyte monitoring device provide for the userinterface of the analyte monitoring device. The analyte monitoringdevice includes a control unit which may include any variety ofprocessing devices—e.g., CPU, processor, microprocessor,microcontroller, etc. The control unit executes the various softwareprograms and applications to provide the user interface to the analytemonitoring device.

In some aspects, the analyte monitoring device provides the necessaryhardware and software to acquire analyte test measurements for apatient. The analyte monitoring device may include a test strip port toreceive test strips and analyze any analyte samples present on the teststrip. For example, the user may insert a test strip into the test stripport and then apply a sample of blood to the test strip so that theanalyte monitoring device can measure the glucose levels of the sample.In some instances, the analyte monitoring device may receive analytereadings from another device—e.g., from an implantable sensor forglucose on demand (GoD) applications, and/or from continuous glucosemonitoring (CGM) devices. In some embodiments, an adapter with one ormore such capabilities may be coupled to the analyte monitoring deviceto provide the device with such capabilities.

In some aspects of the present disclosure, a user interface flow for ananalyte monitoring device is provided. The user interface flow comprisesvarious graphical user interfaces displayed on the analyte monitoringdevice and/or features/functions/settings available or accessible to theuser. The user may navigate between various graphical user interfacesand/or accessing various features and functions of the analytemonitoring device.

It should be understood that the term “graphical user interface” is usedbroadly herein to represent any graphical interface element displayed onthe display. For example, the graphical user interface may comprise agraphical icon, element, picture, video, text box, pop-up window,application window, home screen, etc. Furthermore, it should beunderstood that one or more GUIs may be implemented for variousfeatures, functions and/or settings. Further, different GUIs may becombined in some instances without compromising the underlyingprinciples of the disclosure.

The analyte monitoring device may include a landing (e.g., a homescreen) that is displayed on the display of the analyte monitoringdevice and functions as a starting point or relative starting point.From the home screen the user can navigate to any of the various GUI'sto perform or access various functions and features of the device.

These branches of navigation may be accessed when the user activatestrigger elements on the device. The trigger elements may be any varietyof trigger elements—e.g., buttons, keys, toggle switches, wheels,arrows, etc. The trigger elements may be physical and tangible triggerelements located on the device (e.g., hardware buttons or keys on thehousing or keyboard, etc.) and/or may be nontangible trigger elements(e.g., graphical user interface elements) displayed on the device. Itshould also be understood that the branches of navigation may bedisplayed on the home screen (e.g., as icons) and triggered bycorresponding physical and tangible trigger elements on the housing ofkeyboard. For example, in certain embodiments, a touchscreen display isimplemented and the trigger elements are icons displayed on thetouchscreen. The trigger element is activated by the user touching thecorresponding trigger element (e.g., icon). It should be understood thaticons is used broadly herein to represent any text, image, video,graphic, etc. For example, the trigger element may be suggestive of itsfunction or feature—e.g., an image of a gear representing a triggerelement for accessing the setup menu, an arrow keys, check boxes, toggleswitches, buttons (e.g., with identifying text or image inside), etc. Itshould be understood that the underlying principles of the presentdisclosure are not limited to a touchscreen implementation.

For example, FIGS. 1A-1C illustrate a block diagram representing anoverview of a user interface flow for an analyte monitoring device,according to some embodiments. The block diagrams shown in each of FIGS.1A-1B connect at the reference letters A.

Block diagram 100 is shown comprising a home screen 101 from which theuser may navigate (e.g., via a trigger element on a touchscreen displayor with buttons on the device) to logbook screen 102, setup menu 103,extras menu 104, and reminder screen 116. From logbook 102, the user mayaccess other feature and functions, such as logging insulin 105, viewinglog entry details 106, and viewing various charts and graphs 107. Itshould be appreciated that other features and functions may be availablefrom logbook 102 in other embodiments.

Setup menu 103 enables a user to setup the device—e.g., adjust sound andgraphics 108, set the time and date 109, set the language 110, andperform control solution tests 111. Further, from extras menu 104, theuser may access various features and function related to personalizingthe device 112, viewing statistical data 113 (e.g., trends, targetranges, etc.), viewing/controlling food data and settings 114, andviewing/controlling insulin related data and settings 115 (or other drugrelated data).

From reminders 116, the user may navigate to various features andfunction related to viewing and controlling various reminders (andalerts in some instances).

FIG. 1 also shows navigation from a test screen 117. As shown, after atest result 118 for a test measurement is generated, the user may accessvarious feature and functions from the test result screen 118. It shouldbe appreciated that, in some instances, the user may be automaticallytaken to another feature or function.

Again, it should be appreciated that the user interface flow provided inFIG. 1 is exemplary and should not be construed as limited to suchexample. Furthermore, for the sake of clarity and brevity, not all userinterface screens and features and functions are described for FIG. 1.Further details regarding various example user interfaces that may beimplemented with analyte monitoring systems is described in U.S.Provisional Patent Application Nos. 61/451,488, filed Mar. 10, 2011;61/326,651, filed Apr. 21, 2010; and 61/327,023, filed Apr. 22, 2010,the entireties of which are incorporated herein by reference.

FIG. 2 illustrates a home screen, according to certain embodiments.

Home screen 200 is shown comprising various trigger elements 201A-201Fthat can be activated by the user touching the trigger element on thetouchscreen of the analyte monitoring device. For example, triggerelement 201A navigates to a settings screen; trigger element 201Bnavigates to a reminders screen; trigger element 201C navigates to theextras screen; trigger element 201D navigates to an insulin in bodyscreen; trigger element 201E is a feature that enables the user to turna test strip port light on and off; and trigger element 201F navigatesto a logbook screen.

When the meter is turned on, for example, the home screen may bepresented for the user to access various GUI's, features, and functionsof the device. In some instances, the home screen may include one ormore formats. For example, a date format may be implemented and displaythe date and time on the home screen, such as shown in FIG. 2. It shouldbe understood that other formats may be implemented. In some instances,as pointed out on page 5, a home screen may be customized—e.g., with abackground image or customized text.

In some embodiments, the analyte monitoring device may include a testport and provide the capability to perform test measurements on a fluidsample. For example, a test strip may be received by the test port and asample applied to the test strip. The analyte monitoring device performsa measurement reading on the sample and displays and/or stores thereading on the device.

In some aspects, the analyte monitoring device enables the user to addnotes to provide a more comprehensive analysis at a later time. Forexample, these customized notes may provide additional detailsassociated with measurement readings taken.

As stated before, the analyte monitoring device may specifically relateto glucose monitoring of patients (e.g., diabetics) in both clinical andhome use environments. Patients that use long and/or short-actinginsulin may use glucose measurement readings to estimate if insulin isneeded and how much to use. The analyte monitoring device may includesoftware programs for performing insulin dosage calculations with theanalyte monitoring device. In some instances, the insulin calculationmay take into account factors in addition to a current measurementreading or string of measurement readings. One or more of the followingadditional factors may also be taken into account—e.g., thresholdmaximum and minimum values, trending of measurement readings, times oftests (e.g., whether before and after meals and/or time since last meal,and/or times from last insulin dosage and/or amount of insulin remainingin the body), exercise, meals and food intake (e.g., carbohydratevalues, anticipated carbohydrate values, bread units, serving size,etc.), etc. It should be appreciated that other factors may also betaken into account, and that the example factors are not limiting.

In some aspects, the analyte monitoring device may include insulincalculation features that are available and presented to the user. Forexample, in certain embodiments, the device may include insulin dosagecalculation. For example, the analyte monitoring device may displayvarious screens for entering user inputs regarding such factors andcalculation, and then perform the calculation using those user inputsand displaying the calculated result associated with the suggestedamount of insulin for the patient.

In some aspects, the analyte monitoring device may include settings(and/or configurations) and reminders features that are available andaccessible to the user. For example, in some instances, user interfacesmay be implemented associated with settings for the analyte monitoringdevice and reminders. In some instances, settings allow the user toadjust settings related to date and time, sounds and pictures,languages, control solution tests, etc. A wide range of reminders may beimplemented for various purposes and should not be construed to belimited to these specific examples. One or more types of reminders maybe implemented. For example, reminders relating to measurement tests maybe implemented—e.g., to remind the user to perform test measurements atvarious times and/or upon occurrence of certain events, etc. Certainevents may include, for example, measurement readings at or beyondthreshold level, or projections of measurement readings at or beyond athreshold level. For example, reminders to take a measurement readingmay be provided when a measurement level crosses an upper and lowerthreshold value (e.g., the upper and lower bounds of a target range). Asanother example, reminders to take a measurement reading may be providedwhen an upper and lower threshold level are projected to be crossed. Insome instances, the reminder may not be provided until the time when theupper or lower threshold level was projected to be crossed. Furthermore,the reminders may be provided at various times. For example, upon theoccurrence of the event, the reminder may be provided at a fixted timeafter the occurrence; at a user configured time after the occurrence; ata time based on the reader's actual projection that the threshold wouldhave been crossed; at a time equal to the time horizon of a configurableprojected alarm. In some instances, multiple thresholds may beimplemented with the reminders being provided at different times foreach. For example, a blood glucose threshold of 120 mg/dL may trigger areminder to take another measurement in 15 minutes; another bloodglucose threshold of 130 mg/dL may trigger a reminder to take anothermeasurement in 5 minutes; and yet another blood glucose threshold of 150mg/dL may trigger a reminder to take another measurement in 1 minute.

Furthermore, reminders relating to medication may be implemented—e.g.,to remind the user to take medicine at various times and/or uponoccurrence of certain events. Still further, reminders related toinsulin may be implemented—e.g., to remind the user to take insulin atvarious times and/or upon occurrence of certain events. In someinstances, additional and/or customizable reminders may be implementedin the analyte monitoring device. In some instances, the frequency(e.g., daily, once, etc) of the reminder and/or a countdown timer may beset.

Additional details regarding alarms and reminders may be found in U.S.Nonprovisional patent application Ser. No. 11/555,192, filed Oct. 31,2006, the entirety of which is herein incorporated by reference.

It should be understood that alarms may also be implemented on thedevice and viewed/controlled by the user, in certain embodiments. Thereminders/alarms may take the form of audio, visual, and/or hapticfeedback (e.g., vibratory) reminders. For instance, the reminder may bea particular GUI that pops up on the display to remind the user of theparticular reminder. The GUI may encompass the display or be a smaller“window” that pops up over a current GUI. The reminder could alsoinclude an audio and/or vibratory reminder instead of, or in additionto, the GUI. Furthermore, it should be appreciated that the varioussymbols or icons may also be implemented in place of a pop up window orfull screen GUI. The user may also take various actions upon beingreminded—e.g., dismiss, snooze, confirm, etc.

Various patterns and messages may be implemented in certain embodimentsto provide additional information to the user and/or physician. Patternsmay include, for example, patterns in the data acquired from the analytemonitoring device. For instance, measurement reading patterns overvarious time periods and target ranges may be identified. In someinstances, the patterns may relate to measurement reading patternsassociated with various events (e.g., meals, exercises, insulinadministration, etc.).

Messages may be displayed on the analyte monitoring device to inform theuser of a wide variety of purposes. For example, in some instances, themessages are used to convey identified patterns to the user. Forexample, the user may receive a message via a message icon such as asuggestive ‘envelope’ icon, and may then access the message andinformation regarding one or more patterns. In some instances, thepatterns and/or messages feature may be activated and deactivated by theuser and/or physician.

In some aspects of the present disclosure, the analyte monitoring devicemay enable the user to personalize the analyte monitoring device usingthe analyte monitoring device. Personalization may include, for example,setting audio, visual, and/or haptic feedback (e.g., vibratory) themesfor the analyte monitoring device and GUIs. For example, customizedsounds, images (e.g., background images, icons, etc.), video, vibrationpatterns, etc. may be set by the user. In some instances, the user ispresented with default options that may be chosen. In some instances,the user may upload various personalizations (e.g., images, sounds,etc.) to the device. In some embodiments, the audio, visual, and/orvibratory theme may be presented during a waiting period when performinga test measurement.

FIG. 3 illustrates a flowchart for personalizing an analyte monitoringdevice, according to certain embodiments. A personalization screen 300is shown displaying six pre-installed background images 301-306. Inother embodiments, one or more uploaded background images may bedisplayed as well. The personalization screen 300 may be accessed invarious manners—e.g., via an extras menu on the home screen. A helptrigger element 307 is shown on the personalization screen 300. Ifactivated by the user, the trigger element 307 navigates to the helpscreen 308 that provides additional information regarding thepersonalization screen 300. Trigger element 309 navigates back to thepersonalization screen 300. Upon selection of a pre-installed backgroundimage—e.g., background image 301—a confirmation screen 310 is displayedthat includes the background image 301 displayed in the background. Uponuser confirmation, the device is configured with the background image301 displayed. In other embodiments, the device is configured to displaythe background image 301 when waiting for a measurement result during atest measurement.

In certain embodiments, the personalizing of the analyte monitoringdevice comprises configuring the analyte monitoring device to display auser selected name—e.g., as a banner on the background.

In certain embodiments, the analyte monitoring device comprises ahousing, a strip port coupled to the housing, an output display coupledto the housing, a processor coupled to the housing, and memory operablycoupled to the housing and electrically coupled to the first processor.The memory includes instructions stored therein for personalizing theanalyte monitoring device.

FIG. 3B illustrates an example block diagram for a method that isperformed when the instruction are executed by the processor, accordingto certain embodiments.

At block 320, a user interface is displayed on the output display. Theuser interface enables a user to personalize the analyte monitoringdevice—e.g., to configure the analyte monitoring device to display auser selected background image.

At block 325, the user selects a background image. In some embodiments,a plurality of pre-installed background images is displayed on theoutput display for the user to select from. In other embodiments, theuser may upload a separate background image—e.g., from a storage deviceor from the internet, for example.

At block 330, the device is configured to display the user selectedbackground image. In some embodiments, the background image is displayedon the home screen, for example. In other embodiments, the backgroundimage is displayed during a waiting period for an analyte measurement.

In some aspects of the present disclosure, the analyte monitoring devicemay enable the user to log food and/or view logged food data with theanalyte monitoring device. In some instances, the capability to log foodmay be activated by the user or physician to provide a morecomprehensive view of user data. For example, in some instances, theuser may be provided with the capability to log food after testmeasurements.

In some aspects, the analyte monitoring device provides the capabilityto setup and/or adjust the settings of the insulin calculation feature.In some instances, setup may include, for example, one or more of thefollowing: an introduction or short tutorial that is presented to theuser; a lock feature to lock the calculator settings when complete;adjustment and/or setting of a target range, adjustment and/or settingof a correction range, adjustment and/or setting of a correction factor,adjustment and/or setting of dose increments, adjustment and/or settingof a maximum dose, adjustment and/or setting of a insulin duration;setup of a meal calculator; setup of a servings calculator; setup ofbread units; setup of a carb calculator, etc. In some instances, theuser may be presented with a GUI for reviewing, confirming, and/orediting the insulin calculation settings. In some instances, userinterfaces are provided for locking the calculator settings of theanalyte monitoring device.

In some aspects, the analyte monitoring device provides a logbookfeature to log various data. The data may include measurement reading,data associated with the measurement readings, various events (e.g.,meals, exercises, medication, insulin, etc.), etc., and may be recordedbased on time and/or date of occurrence. Various data may be logged andstored in the device for later analysis and review. For example, in theuser may be presented with the option to log results after measurementsare taken. Additional notes and related information may be included andlogged with the measurement to provide a more comprehensive view of thelogged measurement. Furthermore, the user may access the logbook toreview the data logged and/or review analysis of the data logged (e.g.,statistical data, trends, patterns, averages, etc.). In some aspects,the analyte monitoring device may present the required interface to loginsulin dosages and/or medicine intake. The insulin log may, forexample, account for whether the insulin was long acting or rapidacting, the amount administered, time administered, etc.

In some embodiments, the device may be configured to automaticallydisplay one or more interfaces upon a first start or activation of theanalyte monitoring device, according to some embodiments. The firststart may take into account, for example, the language to be used, date,time, introduction or short tutorial, etc. For instance, the analytemonitoring device may prompt the user to enter, read, confirm, skip,etc., the information provided.

In some aspects, the analyte monitoring device provides an interface forsetting carb data—e.g., setting carb ratios by time of day for thecalculator setup of the analyte monitoring device. In some aspects, theanalyte monitoring device provides an interface for setting correctionfactors—e.g., associated with setting correction factors by time of day,and setting correction factors adjusted for high blood glucose readings,for calculator setup of the analyte monitoring device.

In some instances, the analyte monitoring device may provide a warningand possible remedy. For example, if a user has a low blood sugarreading, the analyte monitoring device may display a warning that theuser's blood sugar is low, and that suggested remedy may provide somerelief—e.g., by taking a set amount of carbs, by suggesting a foodproduct, etc.

Some interface may be associated with setting units on the analytemonitoring device. In some instances, different features may be assigneddifferent units independently.

In some instances, the analyte monitoring device may provide aninterface for the user to account for insulin already taken by the user.In some instances, the analyte monitoring device will take into accountwhether the user has any insulin remaining in their body, and mayinclude requests for user inputs to confirm previous administrationtimes, amounts, etc.

User Interface for a Remote Data Processing Device

In some aspects, the analyte monitoring device may be communicativelycoupled to a remote data processing device for management purposes.Remote device may include, for example, a personal computer, laptop,PDA, cellular phone, smartphone, set-top box, etc. The remote device mayinclude, for example, a control unit including any variety of processor,microprocessor, microcontroller, etc. The remote device may also includea memory unit comprising non-volatile memory and volatile memory.

The term remote device is used herein to represent any device that isexternal to the analyte monitoring device. The remote device may requiresoftware to communicate and manage data from the analyte monitoringdevice. This user interface software (referred to herein as “remotedevice software” or “RD software” to distinguish it from the userinterface software running on the analyte monitoring device) may beobtained from one or more methods such as downloading from the web,CD-ROM, memory stick, etc.

In some embodiments, the analyte monitoring device includes the RDsoftware programs and/or applications to be run on the remote device. Insome instances, the RD software may be configured to automaticallylaunch when the analyte monitoring device is coupled to the computer.For example, the analyte monitoring device may include an installerprogram that is stored in non-volatile memory and executed when theanalyte monitoring device is coupled to the remote device. The installerprogram may be executed when the user couples the analyte monitoringdevice to the remote device. The installer program may then initiate thelaunch of the RD software on the remote device.

In some embodiments, the RD software is not stored in non-volatilememory on the remote device. The RD software is stored on the analytemonitoring device and used to launch the RD software on the remotedevice is coupled to the analyte monitoring device.

In some embodiments, the RD software may be downloaded and stored innon-volatile memory on the remote device. For example, the RD softwaremay be downloaded via a network connection (e.g., via an internetconnection), by storage device (e.g., CD-ROM, memory stick, etc.),and/or downloaded from the analyte monitoring device. In some instances,the RD software is capable of being run even when the device is notcoupled to the computer.

It should be understood that the RD software may be compatible withvarious hardware systems (e.g., PC, MAC) and various operating systems(e.g., Windows, MAC OS, Linux).

The analyte monitoring device may be communicatively coupled to theremote device via wired technologies. Example wired technologies mayinclude, but are not limited to, the following technologies, or familyof technologies: USB, FireWire, SPI, SDIO, RS-232 port, etc.

The analyte monitoring device may include, for example, a communicationconnector unit to permit wired communication and coupling to the remotedevice. The communication connector unit provides the capability tocommunicate with a remote device having an appropriate interface tooperatively couple with the communication connector. In someembodiments, the communication connector is configured to communicatewith a smartphone such as an iPhone or Blackberry.

The communication connector unit may be any variety of connectioninterfaces—e.g., male or female connection interfaces. Using USB as anexample, the communication connector may be any of the variety of USBplugs or USB receptacles/ports. As USB receptacles are typically locatedon computer and other devices, a corresponding USB plug used as acommunication connector unit will enable the analyte monitoring deviceto be plugged directly into the USB receptacle, avoiding the use ofcables. In other instances, the appropriate USB receptacle may be usedon the analyte monitoring device to enable communication using a USBcable (similar to many other devices such as digital cameras, cellularphones, smartphones, etc.).

It should be appreciated that the in some embodiments the analytemonitoring device may be communicably coupled to the remote device viawireless technology. In such instances, the analyte monitoring devicemay include corresponding transmitters, receivers, and/or transceivers.The analyte monitoring device may be configured to wirelesslycommunicate using a technology including, but not limited to, radiofrequency (RF) communication, Zigbee communication protocols, WiFi,infrared, wireless Universal Serial Bus (USB), Ultra Wide Band (UWB),Bluetooth® communication protocols, and cellular communication, such ascode division multiple access (CDMA) or Global System for Mobilecommunications (GSM), etc.

The functionality of the RD software launched on the remote device mayinclude a variety of functions relating to, for example, dataacquisition; data management; management of features, settings,configurations, etc., of the analyte monitoring device; generation,saving, transmitting, and/or printing of reports, management of updates(e.g., field updates to device firmware and RD software); access totraining content, web-based content, web-based marketing; etc.

The RD software may be launched on a remote device and used by the user(e.g., the patient) and/or a health care provider (HCP) (e.g.,physician, hospital staff, etc.). For example, the HCP and/or patientmay use the RD software on a remote device to analyze the patient data,view and print reports, view and change device settings, update devicefirmware and application software, etc.

In some instances, the RD software may initiate a comparison between thetime date on the analyte monitoring device and that on the remote deviceand/or remote time server accessed via an internet connection from theremote device. The RD software may account for discrepancies and takeaction accordingly. For example, thresholds may be set (e.g., 5 minutedifference) and if the threshold is reached, the analyte monitoringdevice prompts the user with a warning, question, indicator, etc., toacknowledge the discrepancy and/or remedy the discrepancy (e.g., adjustthe time on one of the devices). In some instances, a similar comparisonmay be performed by the RD software to account for other discrepanciesbetween the analyte monitoring device and remote device—e.g.,discrepancies between data logs, data values, stored files, deviceand/or user interface configurations and settings, etc. The appropriateaction can then be taken or requested.

Various defaults and customized configurations and settings may beestablished for generating, printing, saving, exporting, etc., reports.For example, the various formats for the report may be established(e.g., layout, style, themes, color, etc.); various file types to savethe report as (e.g., PDF, Word document, Excel spreadsheet, etc. In someinstances, for example, the RD software may provide the user with theability to export tab-delimited text files or XML exports of the meterdata (e.g., including blood glucose, ketones, carbs, insulin, and eventtags, etc.). In some instances, the RD software may enable the user tosave, print, and/or export preferences, including favorite reports,target blood glucose ranges, auto save, auto print, color/black andwhite printing, device/software update settings for multiple devices,etc.

In some aspects, the RD software is used to control the configuration ofthe device and data from the device. This control may be utilized by theuser and/or HCP. In some instances, the RD software shall provide accessto one or more informative documents, trainings, tutorials, etc. Forexample, the RD software application may provide links or tomanufacturer sponsored websites intended for any variety of purposessuch as marketing and training content.

In some aspects, the RD software may include an update managementfunction to help facilitate the detection, download, and installation ofupdates (e.g., firmware, informatics application updates, etc.) for theanalyte meter device and/or the RD software. The updates may be detectedand downloaded automatically in some instances (e.g., when an internetconnection is active) and/or detected and downloaded upon userconfirmation or request. In some instances, updates to the softwareshall also update its installation files stored on the device. Moreover,in some instances, when the device firmware is updated, requiredlabeling/user documentation is also updated on the device. In someinstances, when device firmware is updated, the existing device settingsand testing history (e.g., blood glucose, insulin, carb data, etc.) ispreserved.

FIGS. 4A-4B illustrate a remote data processing device having RDsoftware that enables it to operate with one type of analyte monitoringdevice but not another type of analyte monitoring device. Remote dataprocessing device 400 has RD software installed on it. The softwareloaded onto the device 400 via the internet 403 or a memory device 404.

In FIG. 4A, the device 400 is enabled by the RD software to communicatewith a coupled analyte monitoring device 401 but not with a coupledanalyte monitoring device 402. For example, device 402 may be a legacydevice that requires different RD software. In FIG. 4B, the device 400is enabled by a different RD software to operate with a coupled analytemonitoring device 402 but not with a coupled analyte monitoring device401.

FIG. 4C illustrates a remote data processing device receiving RDsoftware from an analyte monitoring device that enables the dataprocessing device to operate with multiple types of analyte monitoringdevices, according to certain embodiments. Remote data processing device450 is operably coupled to analyte monitoring device that has RDsoftware installed on it. When connected, device 455 transfers the RDsoftware to the device 450, which stores the software therein forexecution. Device 455 may be, for example, a newer model of analytemonitoring device that has the RD software installed on it to enablecompatibility with other types of analyte monitoring devices—e.g.,legacy devices. In some instances, this RD software may be loaded ontothe device 400 via the internet 403 or a memory device 404.

FIG. 4D illustrates device 455 operably connected to any one of theanalyte monitoring devices 401, 402, and 455, according to certainembodiments. It should be appreciated that all three devices are notnecessarily connected at the same time, but are shown that way forillustrative purposes. For example, after device 455 loads the RDsoftware on the device 450, the device 450 may operate with the analytemonitoring device 455. If the analyte monitoring device 455 isdisconnected and another type of analyte monitoring device (e.g., device401 or device 402) is connected, then the device 450 may operate withthe other type of device (e.g., device 401 or device 402).

For example, in certain embodiments, all three devices 401, 402, and 455may be able to perform blood glucose measurements, while only device 455is able to utilize advanced functions, such as, but not limited to,insulin calculation (e.g., bolus and/or basal), ketone bodymeasurements, personalization of the device, carb counting, etc.

FIG. 4E illustrates a block diagram for a method of enabling differentapplication features on a data processing device for analyte monitoringdevices with different analyte monitoring features, according to certainembodiments.

At block 470 of method 400, an indication that a first analytemonitoring device is communicatively coupled to a data processing deviceis received. The first analyte monitoring device includes a firstplurality of analyte monitoring features.

At block 475, a first plurality of application features for the firstanalyte monitoring device is determined. The first plurality ofapplication features is associated with the first plurality of analytemonitoring features. For example, analyte monitoring features mayinclude a feature for performing blood glucose measurements, and theassociated first application features may include a feature fordisplaying recorded blood glucose measurements.

At block 480, the first plurality of application features is enabled onthe data processing device for the first analyte monitoring device.

At block 485, an indication that a second analyte monitoring device iscommunicatively coupled to the data processing device is received. Thesecond analyte monitoring device includes a second plurality of analytemonitoring features. The second plurality of analyte monitoring featuresincludes at least one analyte monitoring feature that is absent from thefirst plurality of analyte monitoring features.

For example, the first analyte monitoring device may be removed from thedata processing device and the second analyte monitoring device coupledto the data processing device. In such case, the RD software initiatesoperation with the second analyte monitoring device. In someembodiments, the current application may stay active but replace anyfirst device-specific data with second device-specific data (e.g.,imported data from the second device, imported or saved profileinformation, etc.). In other embodiments, the application may reset orrestart for operation with the second analyte monitoring device. Anyapplication features from the first plurality of application featuresthat are absent in the second plurality of application features aredisabled.

In some embodiments, the data processing device may indicate the devicethat is being operated using the RD software—e.g., by activating and/orflashing the backlight of the operated device. Other notifications mayalso be provided to make the user aware of the proper device that isbeing operated with the software.

In some instances, the second analyte monitoring device may be coupledto the data processing device while the first analyte monitoring deviceis still coupled. In such case, the RD software may be programmed tooperate with one of the devices—e.g., maintain operation with the firstdevice or begin operation with the second device. This may be indicated,for example, by the backlight on the “operated” device remaining litwhile the backlight on the “non-operated” device is not activated.

In yet other embodiments where two analyte monitoring devices aresimultaneous coupled to the data processing device, the RD softwareopens a second application window for the second analyte monitoringdevice that was added. For example, the second application for thesecond analyte monitoring device runs independent of, and simultaneouslywith, the first application running for the first analyte monitoringdevice. The backlight of the device corresponding to the “active”application window may be lit, for example, to indicate the currentanalyte monitoring device being “operated”.

At block 485, a second plurality of application features for the secondanalyte monitoring device is determined. The second plurality ofapplication features are associated with the second plurality ofanalyte-monitoring features, and the second plurality of applicationfeatures includes at least one application feature that is absent fromthe first plurality of application features. In some embodiments, the atleast one analyte monitoring feature that is absent comprises insulincalculation; and the at least one application feature that is absentcomprises enabling customization of device settings for insulincalculation. The insulin calculation may be, for example, a boluscalculation or a basal calculation. In other embodiments, the at leastone analyte monitoring feature that is absent comprises a ketone bodymeasurement, and the at least one application feature that is absentcomprises displaying recorded ketone body measurements.

At block 490, the second plurality of application features is enabled onthe data processing device for the second analyte monitoring device. Forexample, the RD software may import the data from the second

In some embodiments, application features from the first plurality ofapplication features that are absent in the second plurality ofapplication features are disabled.

In some embodiments, the first plurality of analyte monitoring featuresand the second plurality of analyte monitoring features may include afeature for performing blood glucose measurements, and the firstplurality of application features and the second plurality ofapplication features include a feature for displaying recorded bloodglucose measurements.

In some embodiments, methods may also include receiving an indicationthat a third analyte monitoring device is communicatively coupled to thedata processing device. The third analyte monitoring device includes athird plurality of analyte monitoring features, and the third pluralityof analyte monitoring features include at least one analyte monitoringfeature that is absent from the first and second plurality of analytemonitoring features. A third plurality of application features for thethird analyte monitoring device is determined. The third plurality ofapplication features are associated with the third plurality ofanalyte-monitoring features, and the third plurality of applicationfeatures include at least one application feature that is absent fromthe first and second plurality of application features. And, the thirdplurality of application features is enabled on the data processingdevice for the third analyte monitoring device.

Furthermore, in yet further embodiments, the application features fromthe first plurality and second plurality of application features thatare absent in the third plurality of application features are enabled.

In some aspects of the present disclosure, the analyte monitoring devicetransfers software to the remote data processing device to perform themethods of enabling different application features on a data processingdevice for analyte monitoring devices with different analyte monitoringfeatures. For example, the analyte monitoring device may comprises ahousing, a strip port coupled to the housing, a first processor coupledto the housing; and memory coupled to the housing and electricallycoupled to the first processor. The memory includes the instructionsstored therein for transfer to and execution by a second processor on aremote data processing device.

Exemplary Systems

FIG. 5 illustrates a block diagram of a system including an analytemonitoring device and remote data processing device, according to someembodiments. System 500 is shown to comprising analyte monitoring device501 communicably coupled to remote device 505. In some instances, asshown, remote device 505 may have network access to a network 510 inwhich a second remote device 515 is shown coupled to. It should beunderstood that network 510 may include one or more networks, includingLANs, WANs, and/or the internet.

Analyte monitoring device 501 is shown removably coupled to remotedevice 505 via communication connector unit 422. Communication connectorunit, for example, includes a USB plug which couples with a USBreceptacle 507 in remote device 505. Remote device 505 may includeperipheral devices, such as printer, keyboard, monitor, CD drive, etc.Remote device 505 may also include, as shown, a network interface 530which connects it to network 510. Remote device 515 is also connected tonetwork 510 and may communicate with remote device 505 via network 510.

The following paragraphs describe system 500 during operation, accordingto some embodiments. In some instances, the analyte monitoring devicedescribed is a glucose monitoring device which measures the glucoseconcentration level of a blood sample. It should be understood that thedescription applies equally to other analytes and to other forms ofsamples.

In use, analyte monitoring device 501 receives a test strip 525 formeasuring an analyte level of a sample applied to test strip 525. Teststrip 525 is received at strip port unit 520. Analyte monitoring device501 performs a measurement computation on the sample and the user canview the measurement reading on, for example, a touchsreen display (notshown). The user may also be presented with a menu on the touchscreendisplay to view and select—e.g., menus for storing data, downloadingdata, performing bolus calculations based on the measurement, etc.

The user may couple the analyte monitoring device 501 to remote device505 (e.g., a personal computer) via a communication connector unit. Forexample, the user may decide to store the measurement data and thenchoose to download stored test data (including stored measurementreadings) to a remote device 505.

Analyte monitoring device 501 may then be coupled to remote device 505via communication connector unit 422. Communication connector unit 422may, for example, include a USB plug which couples to a USB receptacle507 on remote device 505.

In some instances, the analyte monitoring device 501 may be powered bythe remote device 505 when coupled via the communication connector unit422. In such case, the user would couple the analyte monitoring device501 to the remote device 505 and then insert test strip 525 into thestrip port 520 to take a measurement reading. In some instances, theanalyte monitoring device includes its own power source, such as buttonor AAA-size batteries, for example, and is not powered by the remotedevice 505.

In some instances, the analyte monitoring device may be “locked” orprevented from performing a test while coupled to the remote device 505.For example, medical device regulations such as high voltage isolationtesting may be required if the analyte monitoring device is configuredto perform tests while coupled to a remote device. Thus, “locking” orpreventing the analyte monitoring device from performing a test whilecoupled to the remote device allows the analyte monitoring device to notbe subjected to the additional testing, if so desired.

In some aspects, the analyte monitoring device 501 may initiate a userinterface application (e.g., RD software) to execute on the analytemonitoring device, and/or the remote device 505 when coupled to theremote device 505. The user interface application may be stored in amemory unit on the analyte monitoring device 501, for example. In someaspects, the user is not required to have previously loaded software onthe remote device 505 to operate with the analyte monitoring device 501.In some aspects, the analyte monitoring device may be configured toinitiate the user interface application automatically upon coupling tothe remote device. It should be understood that the user interfaceapplication may be configured to be compatible with various hardwaresystems (e.g., PC, MAC) and various operating systems (e.g., Windows,MAC OS, Linux).

The user interface application may include, for example, diabetesmanagement related applications. The user interface application mayprovide a variety of menus, selections, charts, alarms, reminders,visual indicators, etc. For example, the user may be presented withmenus and options, such as whether to take a measurement reading, toview stored measurement readings, to store data, to download data, toperform bolus calculation based on the measurement, etc.

The user interface program may, for example, allow the user to performthe following steps: (1) create a replica of the test data stored on theanalyte monitoring device 501, on the remote device 505; and (2)synchronize test data from the analyte monitoring device 501 to thedatabase on the remote device 505. Meter settings and/or usersettings/preferences from the analyte monitoring device may also beincluded in the test data and synchronized with the remote device. Dateand time for the remote device 505 and analyte monitoring device 501 mayalso be synched.

To read test data from the analyte monitoring device 501 and write it tothe remote device 505, it is recognized herein that data in the remotedevice may be organized into tables, which may be organized intorecords, which may be broken down into predefined fields. Similarly, atsome level data will be organized into records with a consistent fieldstructure on the analyte monitoring device 501. The user interfaceapplication may read test data from the analyte monitoring device andwrite it out to tables on the remote device 505. The user interfaceapplication may also read data from table in the remote device 505 andwrite them out to the analyte monitoring device 501. Various types ofdata conversion may be used. For example, data residing in fields in theanalyte monitoring device may be converted from the format it exists inthe analyte monitoring device to a format compatible with the remotedevice, and vice versa. The logical structure of the records in the twosystems may be different.

Remote device 505 may include peripheral devices, such as printer,keyboard, monitor, CD drive, etc. Remote device 505 includes a networkinterface which connects it to network 510 (e.g., the internet). Theuser interface application may provide the user with the option to viewtest data on the monitor, to store test data on storage media (e.g.,CD-ROM, memory card, etc.), further analyze and/or manipulate test data,transmit data to another device), and/or print out test data such ascharts, reports, etc., on the printer.

As shown, remote device 505 may also include a network interface 530(e.g., network interface card (NIC), modem, router, RF front end, etc.)used to connect the remote device 505 to network 510. For example, insome aspects, analyte monitoring device 501 may couple via a USBconnection to the remote device which may be a personal computer orlaptop connected to the internet using a wireless modem and/or router.In some aspects, analyte monitoring device 501 may couple via a microUSB connection to a remote device 505 which is a smartphone having an RFfront end to access a mobile network. The user interface application mayprovide a user interface for using the network connection of the remotedevice 505—e.g., to forward test data to a physician, hospital, healthprovider, and/or other third party located at a second remote device 515on network 510. Appropriate action may then be taken by the receivingparty at the second remote device 515.

Referring back to FIG. 5, the analyte monitoring device may include awireless communication unit, for example, which may include, forexample, a receiver and/or transmitter for communicating with anotherdevice, e.g., remote device 505, a medication delivery device, and/or apatient monitoring device (e.g., a continuous glucose monitoring deviceor a health management system, such as the CoPilot™ system availablefrom Abbott Diabetes Care Inc., Alameda, Calif.), etc. The wirelesscommunication unit may be configured to wirelessly communicate using atechnology including, but not limited to, radio frequency (RF)communication, Zigbee communication protocols, WiFi, infrared, wirelessUniversal Serial Bus (USB), Ultra Wide Band (UWB), Bluetooth®communication protocols, and cellular communication, such as codedivision multiple access (CDMA) or Global System for Mobilecommunications (GSM), etc. In some aspects, the wireless communicationunit is configured for bi-directional radio frequency (RF) communicationwith another device to transmit and/or receive data to and from theanalyte monitoring device 501.

In some aspects, the wireless communication unit may be used tocommunicate with a remote device as described above for thecommunication connector unit. In some aspects where the analytemonitoring device includes a communication connector unit, the wirelesscommunication unit may replace or provide an optional channel ofcommunication for the functions provided by the communication connectorunit discussed above. Referring back to FIG. 5, analyte monitoringdevice 501 may be coupled to remote device 505 via a wirelesscommunication unit and provide an optional alternative communicationchannel with remote device 505. In some aspects, analyte monitoringdevice 501 may not include a communication connector unit 422, andinstead only communicate with the remote device 505 via a wirelesscommunication unit present on analyte monitoring device 501. In someaspects, the analyte monitoring device is configured to receive aprogram update from a remote device via the wireless communication unit.

In some aspects, the wireless communication module may be configured tocommunicate with a smartphone (e.g., iPhone, Blackberry, etc). It istypical for smartphones to include various wireless technologies such asWi-Fi, infrared, Bluetooth®, etc.

In some aspects, the analyte monitoring device may be configured towirelessly communicate via the wireless communication unit with a serverdevice, e.g., using a common standard such as 802.11 or Bluetooth® RFprotocol, or an IrDA infrared protocol. The server device could beanother portable device, such as a Personal Digital Assistant (PDA) ornotebook computer, or a larger device such as a desktop computer,appliance, etc. In some aspects, the server device has a display, suchas a liquid crystal display (LCD), as well as an input device, such asbuttons, a keyboard, mouse or touchscreen. With such an arrangement, theuser can control the meter indirectly by interacting with the userinterface(s) of the server device, which in turn interacts with themeter across a wireless link.

In some aspects, the wireless communication module is used tocommunicate with a remote sensor—e.g., a sensor configured forimplantation into a patient or user. Examples of sensors for use in theanalyte monitoring systems of the present disclosure are described inU.S. Pat. No. 6,175,752; and U.S. patent application Ser. No.09/034,372, incorporated herein by reference. Additional informationregarding sensors and continuous analyte monitoring systems and devicesare described in U.S. Pat. No. 5,356,786; U.S. Pat. No. 6,175,752; U.S.Pat. No. 6,560,471; U.S. Pat. No. 5,262,035; U.S. Pat. No. 6,881,551;U.S. Pat. No. 6,121,009; U.S. Pat. No. 7,167,818; U.S. Pat. No.6,270,455; U.S. Pat. No. 6,161,095; U.S. Pat. No. 5,918,603; U.S. Pat.No. 6,144,837; U.S. Pat. No. 5,601,435; U.S. Pat. No. 5,822,715; U.S.Pat. No. 5,899,855; U.S. Pat. No. 6,071,391; U.S. Pat. No. 6,120,676;U.S. Pat. No. 6,143,164; U.S. Pat. No. 6,299,757; U.S. Pat. No.6,338,790; U.S. Pat. No. 6,377,894; U.S. Pat. No. 6,600,997; U.S. Pat.No. 6,773,671; U.S. Pat. No. 6,514,460; U.S. Pat. No. 6,592,745; U.S.Pat. No. 5,628,890; U.S. Pat. No. 5,820,551; U.S. Pat. No. 6,736,957;U.S. Pat. No. 4,545,382; U.S. Pat. No. 4,711,245; U.S. Pat. No.5,509,410; U.S. Pat. No. 6,540,891; U.S. Pat. No. 6,730,100; U.S. Pat.No. 6,764,581; U.S. Pat. No. 6,299,757; U.S. Pat. No. 6,461,496; U.S.Pat. No. 6,503,381; U.S. Pat. No. 6,591,125; U.S. Pat. No. 6,616,819;U.S. Pat. No. 6,618,934; U.S. Pat. No. 6,676,816; U.S. Pat. No.6,749,740; U.S. Pat. No. 6,893,545; U.S. Pat. No. 6,942,518; U.S. Pat.No. 6,514,718; U.S. Pat. No. 5,264,014; U.S. Pat. No. 5,262,305; U.S.Pat. No. 5,320,715; U.S. Pat. No. 5,593,852; U.S. Pat. No. 6,746,582;U.S. Pat. No. 6,284,478; U.S. Pat. No. 7,299,082; U.S. patentapplication Ser. No. 10/745,878 filed Dec. 26, 1003 entitled “ContinuousGlucose Monitoring System and Methods of Use”; and U.S. Application No.61/149,639 entitled “Compact On-Body Physiological Monitoring Device andMethods Thereof”, the disclosures of each which are incorporated byreference herein.

In some instances, the analyte monitoring device is part of a continuousanalyte monitoring system, where a transcutaneously implanted sensor maycontinually or substantially continually measure an analyteconcentration of a bodily fluid. Examples of such sensors and continuousanalyte monitoring devices include systems and devices described in U.S.Pat. Nos. 6,175,752, 6,560,471, 5,262,305, 5,356,786, U.S. patentapplication Ser. No. 12/698,124 and U.S. provisional application No.61/149,639 titled “Compact On-Body Physiological Monitoring Device andMethods Thereof”, the disclosures of each of which are incorporatedherein by reference for all purposes.

Accordingly, in some aspects, the analyte monitoring device may beconfigured to operate or function as a data receiver or controller toreceive analyte related data from a transcutaneously positioned in vivoanalyte sensor such as an implantable glucose sensor. The analytemonitoring system may include a sensor, for example an in vivo analytesensor configured for continuous or substantially continuous measurementof an analyte level of a body fluid, a data processing unit (e.g.,sensor electronics) connectable to the sensor, and the analytemonitoring device configured to communicate with the data processingunit via a communication link (e.g., using the wireless communicationmodule). In aspects of the present disclosure, the sensor and the dataprocessing unit (sensor electronics) may be configured as a singleintegrated assembly. In some aspects, the integrated sensor and sensorelectronics assembly may be configured as a compact, low profile on-bodypatch device assembled in a single integrated housing and positioned ona skin surface of the user or the patient with a portion of the analytesensor maintained in fluid contact with a bodily fluid such as aninterstitial fluid during the sensor life time period (for example,sensor life time period including about 5 days or more, or about 7 daysor more, or about 14 days or more, or in certain instances, about 30days or more). In such instances, the on-body patch device may beconfigured for, for example, RF communication with the analytemonitoring device to wirelessly provide monitored or detected analyterelated data to the analyte monitoring device based on a predeterminedtransmission schedule or when requested from the analyte monitoringdevice. Predetermined transmission schedule may be programmed orconfigured to coincide with the analyte sample detection by the analytesensor (for example, but not limited to including once every minute,once every 5 minutes, once every 15 minutes). Alternatively, the analytemonitoring device may be programmed or programmable to acquire thesampled analyte data (real time information and/or stored historicaldata) in response to one or more requests transmitted from the analytemonitoring device to the on-body patch device.

In some aspects, wireless communication module of the analyte monitoringdevice includes an RF receiver and an antenna that is configured tocommunicate with the data processing unit, and the processor of theanalyte monitoring device is configured for processing the received datafrom the data processing unit such as data decoding, error detection andcorrection, data clock generation, and/or data bit recovery.

In operation, the analyte monitoring device in some aspects isconfigured to synchronize with the data processing unit to uniquelyidentify the data processing unit, based on, for example, anidentification information of the data processing unit, and thereafter,to periodically receive signals transmitted from the data processingunit associated with the monitored analyte levels detected by thesensor.

In some aspects, the analyte monitoring device may also be configured tooperate as a data logger, interacting or communicating with the on-bodypatch device by, for example, periodically transmitting requests foranalyte level information from the on-body patch device, and storing thereceived analyte level information from the on-body patch device in oneor more memory components.

In some aspects, when the analyte monitoring device is positioned orplaced in close proximity or within a predetermined range of the on-bodypatch device, the RF power supply in the analyte monitoring device maybe configured to provide the necessary power to operate the electronicsin the on-body patch device, and accordingly, the on-body patch devicemay be configured to, upon detection of the RF power from the analytemonitoring device, perform preprogrammed routines including, forexample, transmitting one or more signals to the analyte monitoringdevice indicative of the sampled analyte level measured by the analytesensor. In one aspect, communication and/or RF power transfer betweenthe analyte monitoring device and the on-body patch device may beautomatically initiated when the analyte monitoring device is placed inclose proximity to the on-body patch device. Alternatively, the analytemonitoring device may be configured such that user intervention, such asa confirmation request and subsequent confirmation by the user using,for example, the display and/or input components of the analytemonitoring device, may be required prior to the initiation ofcommunication and/or RF power transfer between the analyte monitoringdevice and the on-body patch device. In a further aspect, the analytemonitoring device may be user configurable between multiple modes, suchthat the user may choose whether the communication between the analytemonitoring device and on-body patch device is performed automatically orrequires a user confirmation.

FIG. 6 illustrates an analyte monitoring device used with a remotesensor, according to some embodiments. Sensor 605 may be configured forimplantation (e.g., subcutaneous, venous, or arterial implantation) intoa patient. The sensor 605 is coupled to sensor control unit 610 which istypically attached to the skin of a patient. The sensor control unit 610operates the sensor 605, including, for example, providing a voltageacross the electrodes of the sensor 605 and collecting signals from thesensor 605. The sensor control unit 610 may evaluate the signals fromthe sensor 605 and/or transmit the signals to wireless communicationunit 423 on analyte monitoring device 501 for evaluation.

In some aspects, the wireless communication unit 423 is configured toreceive a signal from a remote sensor using radio-frequencyidentification (RFID) technology. This configuration may be used toprovide glucose on demand capabilities, in which case when a measurementreading is desired, the analyte monitoring device is brought withinclose vicinity of the implantable sensor. In some instances, RFIDtechnology may be used in continuous glucose monitoring (CGM)applications.

The analyte monitoring device 501 processes the signals from the on-skinsensor control unit 610 to determine the concentration or level ofanalyte in the subcutaneous tissue and may display the current level ofthe analyte via display unit 421. Furthermore, the sensor control unit610 and/or the analyte monitoring device 501 may indicate to thepatient, via, for example, an audible, visual, or othersensory-stimulating alarm, when the level of the analyte is at or near athreshold level. For example, if glucose is monitored then an alarm maybe used to alert the patient to a hypoglycemic or hyperglycemic glucoselevel and/or to impending hypoglycemia or hyperglycemia.

The analyte monitoring device 501 may perform a variety of functions,including for example: modifying the signals from the sensor 605 usingcalibration data and/or measurements from a temperature probe (notshown); determining a level of an analyte in the interstitial fluid;determining a level of an analyte in the bloodstream based on the sensormeasurements in the interstitial fluid; determining if the level, rateof change, and/or acceleration in the rate of change of the analyteexceeds or meets one or more threshold values; activating an alarmsystem if a threshold value is met or exceeded; evaluating trends in thelevel of an analyte based on a series of sensor signals; therapymanagement (e.g., determine a dose of a medication, etc.); and reducenoise or error contributions (e.g., through signal averaging orcomparing readings from multiple electrodes); etc. The analytemonitoring device may be simple and perform only one or a small numberof these functions or the analyte monitoring device may perform all ormost of these functions.

Analyte monitoring device 501 may communicate with a remote device 505via communication connector unit 422, and/or wireless communication unit423, and/or a second wireless communication unit (not shown), asdescribed earlier. It should also be understood that the analytemonitoring device may be configured with one or more wirelesscommunication units.

Software on the Data Processing Device

In some aspects of the present disclosure, software is loaded andlaunched on a remote data processing device to operate with a coupledanalyte monitoring device. The software may include one or more GUI'sfor communicating with the analyte monitoring device. It should beappreciated a GUI may be used to represent one or more of graphicalelements displayed on the display of the remote device for interfacingwith the user. Thus, “graphical user interface” or “GUI” may encompassthe entire display, an application window, pop-up windows, menus,progress and status bars, buttons, etc.

In some aspects of the present disclosure, the RD software provides ameter mode to provide access to settings and functions that are used tosetup and control the analyte monitoring device. The RD software mayalso provide a meter setup mode to guide the user through the initialsetup of the analyte monitoring device. The RD software may provide areports mode to provide access to settings and function for creating,viewing, saving, and/or printing various reports. In addition, the RDsoftware may provide a reports setup mode to guide a user through theinitial reports setup and creation process. The RD software may alsoprovide the function for users to export data from the analytemonitoring device—e.g., as a tab-delimited file or otherspreadsheet-compatible format. In some instances, the RD software mayprovide functions for providing help documents, tutorials, etc. to theuser. The

RD software may provide functions for checking for software update andfor acquiring updates. For example, checks may be automaticallyinitiated and/or initiated by the user. In some instances, the softwareupdates may be checked for and acquired via a network connection on theremote device.

In some embodiments, the RD software provides a user interface to manageand/or control features related to the analyte monitoring device. Insome aspects, the RD software provides an interface to manage and/orcontrol features related to generated reports. For example, the RDsoftware provides a reports mode for creating, editing, viewing,printing, and for performing any other functions associated with reportgeneration and management.

Different types of reports may be generated. For example, FIGS. 7A-7Fillustrate various types of reports, according to certain embodiments.It should be appreciated that the reports illustrated are exemplary andshould not be interpreted as limiting. For the sake of clarity andbrevity, the various reports are briefly described. Further detailsregarding various reports that may be implemented with the software isdescribed in U.S. patent application Ser. No. 11.146,897, filed on Jun.6, 2005, and U.S. Provisional Application Nos. 61/451,488, filed Mar.10, 2011; and 60/577,064, filed Jun. 4, 2004, the entireties of whichare incorporated herein by reference.

Snapshot Report:

In some aspects of the present disclosure, a Snapshot report isprovided. The Snapshot report captures the overall condition of thepatient's health management (e.g., diabetes management). For instance,the report may highlight the key metrics for the user's activities overa specific time period. In some embodiments, the Snapshot report mayprovide significant pieces of information related to one or more of thefollowing: utilization, glucose levels, events (e.g., hypoglycemicevents, ketone events, Hyperglycemic events, etc.), trends, insulin andcarbohydrate data, notes taken, etc. Additional details related to theabove-described information may be found in U.S. Provisional PatentApplication No. 61/451,488, filed on Mar. 10, 2011, the entirety ofwhich is incorporated herein by reference.

FIG. 7A illustrates a Snapshot report for a specific time frame (e.g., atwo week period as shown), according to certain embodiments. Snapshotreport 700 includes various pieces of analyte monitoring relatedinformation displayed on one report. For example, in the embodimentshown, a glucose section 701 and an insulin and carbohydrates section702 is provided. Glucose section 701 includes various data related toglucose measurements for the given time period. For example, the glucosesection 701 displays an indication 703 for the percentage of tests thatwere above target, within target, and below target; an indication 704for standard deviation; and other usage-related indications 705 (e.g.,high, low, and average values; total tests; average tests per day; dayswithout tests; hypo events; ketone events; etc.).

In the embodiment shown, indication 704 provides a graphicalrepresentation of the standard deviation of actual blood glucosemeasurements over the two-week time period with respect to an averageblood glucose value. The indication 704 also shows a comparison to atarget deviation range. In the embodiment shown, the actual standarddeviation of +/−69.7 is within the target standard deviation of +/−100.7from an average value of 201.

Historical trends 706 are also represented within the glucose section701. The historical trends 706 illustrate trends for past blood glucosemeasurements. In the embodiment shown, the time-period shown isdifferent than the time period of the snapshot. In other embodiments,the time period may be the same. Other usage and event data may beprovided for various time periods, such as shown with indication 707.

Indications 708 and 709 are provided in the insulin and carbohydratesection 702 to represent or display various insulin and carbohydraterelated data for the given time period. Furthermore, a notes section 710is also provided and conveys various patterns or bits of information forthe associated data set for the specific time period. In some instances,the notes are generated by the software based on the user's historicaldata. In some instances, the notes are notes that have been entered bythe user.

Logbook Report:

In some aspects of the present disclosure, a Logbook report is provided.A logbook report provides a detailed look at blood glucose readings and,in some cases, other relevant data—e.g., insulin dosage, meals, notes,and ketone events—categorized by time period (e.g., by day). Forexample, FIG. 7B illustrates a Logbook report, according to certainembodiments. Logbook report 720 presents blood glucose readings inaddition to information related to carb, insulin, notes. In FIG. 7B, thelogged glucose readings for a selected time period (in this case2-weeks) is provided in the report. Only one page is shown thatcomprises data for four days 721, 722, 723, and 724 along a time scale725 for each day. Each day is broken up in time to identify variousreadings and other events (e.g., carb entries, insulin entries, notes,etc.). Daily totals 726 are also provided along with indications formeasurements that are above or below target.

Daily Statistics Reports:

In some aspects of the present disclosure, a Daily Statistics report isprovided. The Daily Statistics report highlights and details data forglucose readings within a single day. The data may be used to assist inthe identification of causes of hypoglycemic events and otherabnormalities, for example. For example, FIG. 7C illustrates a DailyStatistics Report, according to certain embodiments. The DailyStatistics Report 730 includes plotted glucose data 731 for timesthroughout the day. The target range 732 is indicated with shading toprovide a quick and easy way to see when the readings are within oroutside the target range. Additional recorded information (e.g., carbs,insulin, notes, and ketones) are provided on the graph below eachassociated reading to remain in the same time-frame context.

Meal Event Averages Reports:

In some aspects of the present disclosure, a Meal Event Averages reportis provided. A Meal Event Averages report communicates the rise and fallin glucose levels relative to meals. For example, FIG. 7D illustrates aMeal Event Averages report, according to certain embodiments. Meal EventAverages report 740 presents glucose data before and after meals, over aset timeframe—e.g., in the morning 741, midday 742, and evening 743. Agraph is shown, for example, that includes both a pre-meal target rangeand a post-meal target range in relation to a time a meal occurred. Theuser's glucose readings are provided on the graph to indicate the user'sglucose readings before and after the meal. The graph may be dividedinto incremental time periods.

Pre-meal insulin and carb information are also provided on the report incharts 744 for each timeframe 741,742,743 for each day of the given timeperiod (e.g., two week time period). In addition, other associatedinformation is provided, such as the number of carbs associated withthat meal, the amount of insulin (e.g., fast-acting and/or long-actinginsulin) taken, etc., may be provided in report 740

Modal Day Reports:

In some aspects of the present disclosure, a Modal Day report isprovided. A Modal Day report communicates the trend in glucose levelsbased across a time period, such as a typical or average day. Forexample, the embodiment shown in FIG. 7E illustrates a Modal Day report,according to certain embodiments. Modal Day report 750 includesvisualization 751 for the trend of average glucose levels across atypical day. Areas containing averages that fall above or below targetmay be color-coded, as illustrate by different shading in ranges752,753,754. Tabular data 755 is also provided below the visualization751 to provide relevant statistics for each time period shown in thevisualization 751.

The modal day reports may also include information that representsdistribution of the measurement related data. For example, the reportmay indicate the percentage of measurements that were within a targetrange, the percentage of measurements that were above the target range,and the percentage of measurements below the target range. As anotherexample, the number of measurements falling within a percentile rangefor the measurements taken may be indicated in the report—e.g., thenumber of measurements falling within the top twenty fifth percentile,bottom twenty fifth percentile, etc.

Meter Settings Report:

In some aspects, a Meter Settings Report is provided. The Meter

Settings Report provides the user with a quick synopsis of pertinentmeter settings. Some meter settings may be related to the glucosedata—e.g., settings of glucose targets, thresholds, insulin calculation,correction factors, etc. For example, FIG. 7F illustrates a metersettings report, according to certain embodiments. Meter Settings Report760 comprises sections for profile settings 761, glucose target settings762, extra settings (e.g., insulin related settings) 763, note settings764, and reminder settings 765.

It should be appreciated that other reports may also be provided.

Additional example reports may include, but are not limited to, Calendarreports (e.g., 30 or 90 day summaries); Usage reports that providedetails about the meter utilization to indicate user engagement;Hypoglycemic Events Reports that focus on the hypoglycemic events thatoccurred in a specific time frame; etc.

Personalization of an Analyte Monitoring Device using a Remote DataProcessing Device

In some aspects of the present disclosure, a remote data processingdevice is used to personalize an analyte monitoring device. The remotedevice may include software that enables a user to personalize ananalyte meter that is coupled to the remote device.

FIG. 8 illustrates an example user interface for personalizing ananalyte monitoring device with a remote data processing device,according to certain embodiments. User interface 800 includes variouspre-installed background images 801 that may be selected by a user fordisplay on the analyte monitoring device. The selected background imagemay be, for example, displayed on the home screen in some instances. Inother instances, the analyte monitoring device may be configured todisplay the background image during a waiting period during a testmeasurement. As shown, the user has selected the piano image 801A (e.g.,the user may be a piano player) for display on the analyte monitoringdevice. Upon selection, the selected background image 801A is displayedon the analyte monitoring device at the appropriate time and screen, asshown in FIG. 9. FIG. 9 illustrates an analyte monitoring deviceconfigured with a personalized background image, according to certainembodiments. After the user selection (and confirmation in someinstances) shown in FIG. 8, the analyte monitoring device 900 includesthe selected background image 801A displayed on the background of thehome screen. In other embodiments, the background image 801A is onlyshown during a waiting period during a test measurement.

Methods for personalizing an analyte monitoring device with a remotedata processing device may comprise receiving an indication that ananalyte monitoring device is communicatively coupled to the remote dataprocessing device; and displaying a user interface on the remote dataprocessing device that enables a user to personalize the analytemonitoring device. For example, the user may be able to configure theanalyte monitoring device to display a user selected background image.The methods may further comprise receiving input for a user selectedbackground image, and configuring the analyte monitoring device todisplay the user selected background image.

In some embodiments, the methods comprise displaying a plurality ofpre-installed background images on an output display of the remote dataprocessing device so that the user may select one. In some instances,the user may select a different background image that is stored on amemory device or located on the internet, for example, and then uploadedto the device.

In some instances, the methods may comprise personalizing the analytemonitoring device by configuring the analyte monitoring device todisplay a user selected name. In some instances, user input may beentered from the remote data processing device. In other instances, theuser input may be entered from the analyte monitoring device.

Time Based Advanced Programming of an Analyte Monitoring Device

In some aspects, one or more configuration settings and/or userinterface settings for the analyte monitoring device may bepre-programmed prior to a future clinical visit and be based on a timeperiod relative to a future event (e.g., a future visit, such as thenext future visit). The analyte monitoring device may then bepre-programmed, for example, by the HCP during a current clinical visitby the patient, for a time period in the future based on a future eventsuch as the next clinical visit by the patient. For example, the HCP maypre-program the device for two weeks prior to a future clinical visit.

In some embodiments, the time period begins in the future from the timewhen the device is pre-programmed. In some instances, the time periodbegins more than one day after the day the device is pre-programmed,including a time period beginning more than 2 days after the day thedevice is pre-programmed, for example a time period beginning more thanone week after the device is pre-programmed.

Thus, if the time between visits is too long of a time period to gatherdata, the HCP may set a future time period based on the next clinicalvisit. For example, if a patient is at a current clinical visit and thenext clinical visit is three months later, but three months of data ismore than the HCP desires, the HCP may pre-program the device for anappropriately desired time period prior to the next clinical visit—e.g.,2 weeks, 1 month, etc.

In some embodiments, the pre-programming of the device includesbeginning to gather data at the specified time period. For example,prior to the beginning of the time period, the user may still use theglucose monitor to monitor his glucose without data being gathered.

In other embodiments, the pre-programming of the device includespre-programming the device to enter a different data gathering mode whenthe time period begins. Thus, the device switches to a different datagathering mode when the time period begins. For instances, after thepatient leaves the office, the patient will continue with his usualglucose monitoring schedule until the time period established prior tothe next scheduled visit. When the time period is reached, the glucosemonitor with the advanced programming routine will “switch” the mode ofoperation and provide additional UI, reminder, and alarm based on thetime based advanced programming. The patient may then follow theprescribed reminders and alarms to collect the additional data that thedoctor wanted right before the clinical visit in order to betterfacilitate diagnosis and optimize treatment.

The analyte monitoring device may be pre-programmed to account for avariety of configuration settings and/or user interface settings. Thismay include instructions or aids for the user (e.g., summary checklistsfor all the various glucose readings to be obtained in the time period,various reminders and alarms (e.g., reminders to take glucose readings),thresholds, user interface elements, or any other configuration settingand/or user interface settings such as the ones described herein.

The advanced programming of this data “gathering” mode switch can bedone at the clinic, for example, as part of the HCP providing newrecommendations for the self management routine. In some embodiments,the RD software is used to manage data analysis and therapy change inthe clinic (e.g., to pre-program the device) and can be used to providea more user friendly tool to program the device. For example, the HCPmay plug the analyte monitoring device into a computer causing the RDsoftware application to launch on the computer, subsequentlypre-programming the device via the computer. In some embodiments, thetime based advanced programming can be done on the analyte monitoringdevice itself, through the corresponding configuration graphical userinterface presented on the device.

The time period may be preprogrammed into the device as well as anyattributes of the data gathering mode that is to be entered during thetime period. The time period may include, for example, starting andending dates in the future, only a starting date in the future, etc. Theattributes of the data gathering mode may, for example, include theadding of three more SMBG readings 2 hours after each meal, atapproximately 10 am, 2 pm, and 9 pm. The attributes may include otherrelevant thresholds for UI, alarms, and/or reminders that make up thedata gathering mode (e.g., reminder only, reminder+alarm, dailychecklist, weekly checklist, etc.). Furthermore, in some instances, thetime of the next clinical visit may be entered. The time period may, forexample, in such case, identify the time period prior to the dateentered for the next clinical visit.

It should be appreciated that in some embodiments, more than one futuretime period may be pre-programmed if desired.

Condition Based Advanced Programming of an Analyte Monitoring Device

In some aspects, one or more configuration settings and/or userinterface settings for the analyte monitoring device may bepre-programmed prior to a future clinical visit and be based on a futuredata condition obtained by the analyte monitoring device prior to thenext clinical visit. The discussion above for time based advancedprogramming applies here to condition based advanced programming, exceptthat the trigger for the entry into the pre-programmed mode is based onthe occurrence of a future condition rather than a future time periodrelative to a future event (e.g., the next clinical visit).

The data condition may be any variety of conditions related to the datataken by the analyte monitoring device. For example, the data conditionmay be associated with, but not limited to, measurement readings,thresholds, trends, patterns, other events (e.g., meal events, carblevel thresholds, exercise events, state of health, etc.), etc. In someinstances, the events may be user-entered.

For example, if a HCP finds that a pattern exists where whenever thepatient has a pre-prandial glucose of less than 110 mg/dL (e.g., notevery meal, but frequently occurring), the patient has a tendency to golow 3 hours after the meal. The HCP may decide to, for example,recommend the patient adjust the bolus calculator recommended meal bolusreadings whenever a pre-meal SMBG is below 110 mg/dL, and at the sametime pre-program the device to turn on this data gathering feature. Iffuture condition occurs, the device then enters the pre-programmed datagathering mode. The pre-programmed data gathering mode may includeconfiguration settings and/or user interface settings that, for example,provide the user with reminders, alarms, instructions, etc. For example,upon occurrence of the future condition, the data collection mode ay beactivated, reminders sent to the patient on what to do (e.g., lowerinsulin by 2-5%), and alarm the patient regularly to check SMBG afterthat meal at regular intervals (e.g., 2, 3, 4, and 5 hours after themeal) in order to detect and mitigate potential lows). In someembodiments, the patient would have the option to turn off one or moresettings (e.g., the interval alarms described above, etc.). In someembodiments, the settings will be locked so the user cannot change anyof the settings.

When the patient leaves the office, for example, he may continue withhis normal monitoring schedule and routine and attempt to follow the newdosing algorithm for these meal boluses when his pre-meal BG falls below110 mg/dL. The condition based pre-programming will be activated uponoccurrence of the condition and assist the user, for example, to obtainthe additional data. This additional data may then be review by the HCPduring the next visit and analyzed to evaluate the new routine.

One or more attributes of the condition based advanced programming maybe entered (e.g., via the RD software application launched on a remotedevice, and/or on the user interface of the analyte monitoring deviceitself).

The detected condition that will trigger the activation of the datagathering mode may be preprogrammed into the device. In some instances,one or more of the following example attributes may be entered: theduration of the data collection activation after the detected conditionmay also be entered (e.g., number of minutes, hours, days, weeks, etc.);an SMBG reminder schedule and/or other reminder schedule (e.g., onetime, recurring every hour, x-hours, daily, weekly, etc.); SMBG alarmschedule and/or other alarm schedule (e.g., one time, recurring everyhour, x-hours, daily, weekly, etc.), etc.

Graphical Representation of Insulin on Board

In some aspects, the analyte monitoring device may be configured tographically represent the amount of insulin remaining in the user'sbody. Knowing the insulin on board helps to avoid bolus stacking oroverlapping of multiple boluses taken by the user. The graphicalrepresentation provides a different and more intuitive way to displayand present the insulin on board to the user than by presenting anumerical value.

A graphical user interface element may be presented on the display ofthe analyte monitoring device to indicate the insulin on board (IOB orBolus on Board). In some embodiments, the insulin on board isrepresented as a “gauge” to provide the user with an indication as tothe amount of insulin remaining in the body. The exact value is notrequired but rather a general indication as to how much insulin remains.In some instances, the graphical user interface element includes markersto indicate a maximum and minimum amount of insulin along with anindication element of the current amount of insulin remaining in thebody (indicated at or between the maximum and minimum).

For example, in some embodiments, the current amount of insulinremaining in the body is represented by a fill-level of the graphicaluser interface element (i.e., the indication element is the filling).The graphical interface element is thus a fill-level indicator. Thegraphical element is provided and the amount that the graphical elementis filled represents the amount or percentage of insulin remaining inthe body. For example, if the graphical element is completely unfilled,then no insulin remains. If the graphical element is completely filled,then 100% of the insulin remains. The user can easily and quicklyidentify the approximate percentage that the graphical element is filledand thus obtain an approximate understanding of the amount or percentageremaining in the body. FIGS. 10A-10B illustrate an example graphicaluser interface element that functions as a fill-level indicator,according to some embodiments. Bar 1001 is shown approximately 100%filled and represents the amount of insulin remaining in the body aftera bolus was delivered. Bar 1002 is shown approximately 30% filledindicating approximately 30% insulin on board remaining from the amountpreviously delivered. In the embodiment shown, a bar is shown, howeverit should be understood that other shapes (e.g., triangles, circles,etc.) and orientations (vertical, horizontal, etc.) may be implemented.

In some embodiments, the graphical user interface element includesmarkers indicating a maximum and minimum, and the current amount ofinsulin remaining in the body is indicated by an indicator elementbetween the maximum and minimum graphical indications. The indicatorelement may be, for example, an arrow pointing to a point between themaximum and minimum. Where the indicator element resides relative to themaximum and minimum indications provides the user with an approximatepercentage or value remaining in the body. It should be understood thatother forms of indicator elements may be used such as a line, dot, star,icon, or any other form of graphic. For example, the level in the bar inFIGS. 10A-10B may be represented by a single line, and not necessarily“filled”.

FIGS. 11A-11B illustrate an example graphical user interface elementrepresenting insulin remaining in a body, according to some embodiments.Gauge 2001 is shown approximately 100% filled and represents the amountof insulin remaining in the body after a bolus was delivered. Gauge 2002is shown approximately 30% filled indicating approximately 30% insulinon board remaining from the amount previously delivered. In someinstances, additional identifying markers may be present in thegraphical user interface to indicate divisions, approximate values,thresholds, etc. For instance, as shown in FIGS. 11A-11B, threeadditional identifying markers are present to indicate divisions byquarters (i.e., 25% full, 50% full, and 75% full).

In some aspects of the present disclosure, methods for graphicallyrepresent a remaining insulin level in a user body are provided. Themethods comprise displaying a first marker on the output display toindicate a maximum amount of insulin; displaying a second marker on theoutput display to indicate a minimum amount of insulin; and displaying aindication element on the output display to indicate a current amount ofinsulin in the user body, wherein the positional relation of theindication element to the first and second markers is approximatelyproportional to the percentage of insulin remaining in the body.

In some embodiments, the indication element may be, for example, afill-level of a graphical element, wherein the second marker is at oneend of the graphical element and corresponds to a zero percentfill-level, and wherein the first marker is at an opposite end of thegraphical element and corresponds to a one hundred percent fill-level.

In some embodiments, the graphical element is body-shaped, and whereinthe second marker is at a foot-end of the body-shaped graphical element,and wherein the first maker is at a head-end of the body-shapedgraphical element. For example, FIG. 12A and 12B illustrate a graphicalelement representing insulin in the body, according to certainembodiments. Graphical element 1200 is a body-shaped graphical elementwherein the element is filled from the foot end 1202 to the head end1201 of the element. The percentage of the element filled isproportional to the percentage of insulin remaining in the body.

In other embodiments, the indication element is an arrow pointing to aposition at or between the first marker and the second marker. In someinstances, the methods comprise displaying one or more identifyingmarkers between the first marker and second marker to representdivisions, approximate values, or thresholds.

Line Graph Data Representation for Glucose-On-Demand Systems

In some aspects, the analyte monitoring device may be configured withoutmemory for storing measured glucose values. For example, an on-body unitmay not record measurements, and the user initiates a read when ameasurement reading is desired. For example, analyte monitoring relateddata may be provided during an on-demand reading. Such analytemonitoring related data may include magnitude data, as well asrate-of-change data, for the on-demand measurement.

In some aspects of the present disclosure, methods of providing agraphical representation of such on-demand readings are provided. Themethods may include outputting a graphical representation of the analytemonitoring related data that includes graphical elements plotted atlocations corresponding to the magnitude values of the on-demandreadings. Furthermore, the graphical elements visually represent therate-of-change data for each on-demand reading. For example, in someembodiments, the graphical element may be an arrow that is plotted atthe corresponding magnitude value on a chart. The direction ororientation of the arrow may indicate the rate-of-change of thatspecific on-demand reading. For example, an upward pointing arrow mayindicate an upward trend. Further, the degree of incline of the upwardpointing arrow may indicate the degree of the upward trend. Similarly,downward pointing arrows may represent a downward trend. In someinstances, the arrows may match the arrows presented on the userinterface of the analyte monitoring device. In other embodiments, acolor or size of the graphical element may indicate the direction and/ordegree of rate-of-change.

FIG. 13A illustrates a plot for continuous glucose measurements. FIG.

13B illustrates a plot of magnitudes for on-demand measurements for thesame glucose pattern. As shown, FIG. 13B does not provide the user withmuch information in addition to the actual glucose value readings.Trending and other patterns are not discernable. In FIG. 13C, magnitudedata of the on-demand measurements are provided in addition torate-of-change data. As shown, an arrow is illustrated at each on-demandreading and the location of the arrow represents the magnitude of thereading. Furthermore, the direction of the arrow correlates to therate-of-change of the reading at that instant. Furthermore, the degreeof the arrow conveys the degree of the rate-of-change—e.g., with steeperpointing upward arrows and downward arrows correlating to a largerrate-of-change in the corresponding direction. Thus, in FIG. 13C, theuser is able to discern whether glucose values are stable, rising, orfalling.

In another aspect, the glucose rate of change information and the timingbetween glucose values is used to determine rules for when a line isdrawn on the graph connecting subsequent glucose values. For example, iftwo values are taken in close proximity (e.g., less than 30 minutesapart) and the rate-of-change observed at the time of the first readingindicated a rising trend and the second glucose value was greater thanthe first, then the points may be connected by a line. The line may be,for example, dotted, color coded, or otherwise represented to indicateto the user that it is a “fit” to the data and does not representadditional measured glucose values. Alternatively, an autoregressiveapproach is used to connect the points when there is sufficient datadensity and when the subsequent glucose value falls within the rangepredicted by the autoregressive mode.

In some embodiments, a standard spline technique is used to connect thedots with curves instead of straight lines. Other model based approachesare also possible—e.g., that use both glucose and glucose rates toproduce a continuous profile. For example, a standard stochastic stateobserver may be used to predict forward from one point and/or predictbackward from the next point. In this way, it may provide the predictionerror forward and backward. The forward and backward predication curvesbetween the two points may be combined as one weighted prediction error.For example, the prediction error may be represented by the followingequation:

F(t)=[P ⁺(t)*(1/E ⁺(t))̂2+P ⁻(t)*(1/E ⁻(t))̂2]/[(1/E ⁺(t))̂2+(1/E ⁻(t))̂2]

Wherein F(t) is the resulting line, P⁺(t) is the forward predictionline; P⁻(t) is the backward prediction line; E⁺(t) is the forwardprediction error; E⁻(t) is the backward prediction error.

FIG. 14 illustrates a plot using such a prediction error, according tocertain embodiments. As shown, data for on-demand readings 1401 and 1402are provided on a graph 1400. Forward prediction line P⁺(t) and backwardprediction line P⁻(t), and corresponding forward prediction error E⁺(t)and backward prediction error E⁻(t) are used to provide resulting line1403 between the two points 1401 and 1402. If the error E⁺(t) or E⁻(t)exceeds a predetermined threshold, for example 10 mg/dL or 30 mg/dL,then a line connecting the points won't be drawn but rather the gap willbe left.

Protection of Access to Features on an Analyte Monitoring Device

In some aspects, the analyte monitoring device may be configured toprevent the user from accessing specific features of the analytemonitoring device. The user may be blocked access from specific featuresfor any variety of reasons, such as proficiency of the subject matterrelated to the feature, non-applicability of the feature to the patient,etc. For example, many advanced features such as bolus calculators andbasal titration algorithms require a user to be proficient in knowledgeand management of their disease state in order to be used safely andeffectively. The user may not have the required knowledge or training touse such features properly.

In some aspects, the analyte monitoring device may be configured withsoftware protection mechanisms to ensure the user does not have accessto specific features. In some instances, the software protectionmechanisms may be implemented to confirm that the user is qualified touse the feature. The software protection mechanism may implement a testto certify that the user is qualified to use the feature. In someinstances, the software protection mechanism may present the user with aseries of one or more questions that demonstrates the user is proficientin the subject matter related to the feature to be unlocked. Forexample, a protection screen that allows access to a bolus calculatorfeature may check that a user understands carb counting (e.g., by askingthem to answer one or more questions on the number of carbs in a sliceof bread), and/or correction factor (e.g., by asking one or morequestions related to correction factor), etc. In some instances, thequestion may be presented in a multiple choice format. In order toprovide additional protection against an unqualified user trying toaccess a feature by randomly guessing answers, the functionality can belocked out after a number of attempts, and unlocked by password, specialkey, etc.

In some instances, the HCP may confirm the user is qualified to use thefeature and unlock access to the feature. For example, the HCP maypossess the appropriate password or key necessary to unlock the feature.

It should be understood that techniques introduced herein can beimplemented by programmable circuitry programmed or configured bysoftware and/or firmware, or they can be implemented entirely byspecial-purpose “hardwired” circuitry, or in a combination of suchforms. Such special-purpose circuitry (if any) can be in the form of,for example, one or more application-specific integrated circuits(ASICS), programmable logic devices (PLDs), field-programmable gatearrays (FPGAs), etc.

Software or firmware implementing the techniques introduced herein maybe stored on a machine-readable storage medium and may be executed byone or more general-purpose or special-purpose programmablemicroprocessors. A “machine-readable medium”, as the term is usedherein, includes any mechanism that can store information in a formaccessible by a machine (a machine may be, for example, a computer,network device, cellular phone, personal digital assistant (PDA),manufacturing took, any device with one or more processors, etc.). Forexample, a machine-accessible medium includes recordable/non-recordablemedia (e.g., read-only memory (ROM); random access memory (RAM);magnetic disk storage media; optical storage media; flash memorydevices; etc.), etc. The term “logic”, as used herein, can include, forexample, special purpose hardwired circuitry, software and/or firmwarein conjunction with programmable circuitry, or a combination thereof.

The preceding merely illustrates the principles of the presentdisclosure. It will be appreciated that those skilled in the art will beable to devise various arrangements which, although not explicitlydescribed or shown herein, embody the principles of the presentdisclosure and are included within its spirit and scope. Furthermore,all examples and conditional language recited herein are principallyintended to aid the reader in understanding the principles of thepresent disclosure and the concepts contributed by the inventors tofurthering the art, and are to be construed as being without limitationto such specifically recited examples and conditions. Moreover, allstatements herein reciting principles, aspects, and aspects of thepresent disclosure as well as specific examples thereof, are intended toencompass both structural and functional equivalents thereof.Additionally, it is intended that such equivalents include bothcurrently known equivalents and equivalents developed in the future,i.e., any elements developed that perform the same function, regardlessof structure. The scope of the present disclosure, therefore, is notintended to be limited to the exemplary aspects shown and describedherein. Rather, the scope and spirit of present disclosure is embodiedby the appended claims.

1. An analyte monitoring device, comprising: a housing; a strip portcoupled to the housing; a first processor coupled to the housing; andmemory coupled to the housing and electrically coupled to the firstprocessor, wherein the memory includes instructions stored therein fortransfer to and execution by a second processor on a remote dataprocessing device, the instructions for enabling different applicationfeatures on the data processing device for analyte monitoring deviceswith different analyte monitoring features, the instructions comprising:instructions for receiving, with the second processor, an indicationthat a first analyte monitoring device is communicatively coupled to adata processing device, wherein the first analyte monitoring deviceincludes a first plurality of analyte monitoring features; instructionsfor determining, with the second processor, a first plurality ofapplication features for the first analyte monitoring device, whereinthe first plurality of application features are associated with thefirst plurality of analyte monitoring features; instructions forenabling, with the second processor, the first plurality of applicationfeatures on the data processing device for the first analyte monitoringdevice; instructions for receiving, with the second processor, anindication that a second analyte monitoring device is communicativelycoupled to the data processing device, wherein the second analytemonitoring device includes a second plurality of analyte monitoringfeatures, and wherein the second plurality of analyte monitoringfeatures include at least one analyte monitoring feature that is absentfrom the first plurality of analyte monitoring features; instructionsfor determining, with the second processor, a second plurality ofapplication features for the second analyte monitoring device, whereinthe second plurality of application features are associated with thesecond plurality of analyte-monitoring features, and the secondplurality of application features include at least one applicationfeature that is absent from the first plurality of application features;and instructions for enabling, with the second processor, the secondplurality of application features on the data processing device for thesecond analyte monitoring device.
 2. The analyte monitoring device ofclaim 1, wherein the instructions comprise: instructions for disabling,with the processor, application features from the first plurality ofapplication features that are absent in the second plurality ofapplication features.
 3. The analyte monitoring device of claim 1,wherein the analyte is glucose.
 4. The analyte monitoring device ofclaim 1, wherein the first plurality of analyte monitoring features andthe second plurality of analyte monitoring features include a featurefor performing blood glucose measurements, and wherein the firstplurality of application features and the second plurality ofapplication features include a feature for displaying recorded bloodglucose measurements.
 5. The analyte monitoring device of claim 1,wherein the at least one analyte monitoring feature that is absentcomprises insulin calculation; and wherein the at least one applicationfeature that is absent comprises enabling customization of devicesettings for insulin calculation.
 6. The analyte monitoring device ofclaim 5, wherein the insulin calculation is bolus calculation.
 7. Theanalyte monitoring device of claim 5, wherein the insulin calculation isbasal calculation.
 8. The analyte monitoring device of claim 1, whereinthe at least one analyte monitoring feature that is absent comprisesketone body measurement, and wherein the at least one applicationfeature that is absent comprises displaying recorded ketone bodymeasurements.
 9. The analyte monitoring device of claim 1, comprising:instructions for receiving, with the processor, an indication that athird analyte monitoring device is communicatively coupled to the dataprocessing device, wherein the third analyte monitoring device includesa third plurality of analyte monitoring features, and wherein the thirdplurality of analyte monitoring features include at least one analytemonitoring feature that is absent from the first and second plurality ofanalyte monitoring features; instructions for determining, with theprocessor, a third plurality of application features for the thirdanalyte monitoring device, wherein the third plurality of applicationfeatures are associated with the third plurality of analyte-monitoringfeatures, and the third plurality of application features include atleast one application feature that is absent from the first and secondplurality of application features; and instructions for enabling, withthe processor, the third plurality of application features on the dataprocessing device for the third analyte monitoring device.
 10. Theanalyte monitoring device of claim 9, comprising: instructions fordisabling, with the processor, application features from the firstplurality and second plurality of application features that are absentin the third plurality of application features.
 11. An article ofmanufacture, comprising: a machine-readable medium havingmachine-executable instructions stored thereon for execution by aprocessor to control user access to features of an analyte monitoringdevice, the instructions comprising: instructions for receiving, withthe processor, an indication that a first analyte monitoring device iscommunicatively coupled to a data processing device, wherein the firstanalyte monitoring device includes a first plurality of analytemonitoring features; instructions for determining, with the processor, afirst plurality of application features for the first analyte monitoringdevice, wherein the first plurality of application features areassociated with the first plurality of analyte monitoring features;instructions for enabling, with the second processor, the firstplurality of application features on the data processing device for thefirst analyte monitoring device; instructions for receiving, with theprocessor, an indication that a second analyte monitoring device iscommunicatively coupled to the data processing device, wherein thesecond analyte monitoring device includes a second plurality of analytemonitoring features, and wherein the second plurality of analytemonitoring features include at least one analyte monitoring feature thatis absent from the first plurality of analyte monitoring features;instructions for determining, with the processor, a second plurality ofapplication features for the second analyte monitoring device, whereinthe second plurality of application features are associated with thesecond plurality of analyte-monitoring features, and the secondplurality of application features include at least one applicationfeature that is absent from the first plurality of application features;and instructions for enabling, with the processor, the second pluralityof application features on the data processing device for the secondanalyte monitoring device.
 12. The article of manufacture of claim 11,wherein the instructions comprise: instructions for disabling, with theprocessor, application features from the first plurality of applicationfeatures that are absent in the second plurality of applicationfeatures.
 13. The article of manufacture of claim 11, wherein theanalyte is glucose.
 14. The article of manufacture of claim 11, whereinthe first plurality of analyte monitoring features and the secondplurality of analyte monitoring features include a feature forperforming blood glucose measurements, and wherein the first pluralityof application features and the second plurality of application featuresinclude a feature for displaying recorded blood glucose measurements.15. The article of manufacture of claim 11, wherein the at least oneanalyte monitoring feature that is absent comprises insulin calculation;and wherein the at least one application feature that is absentcomprises enabling customization of device settings for insulincalculation.
 16. The article of manufacture of claim 15, wherein theinsulin calculation is bolus calculation.
 17. The article of manufactureof claim 15, wherein the insulin calculation is basal calculation. 18.The article of manufacture of claim 11, wherein the at least one analytemonitoring feature that is absent comprises ketone body measurement, andwherein the at least one application feature that is absent comprisesdisplaying recorded ketone body measurements.
 19. The article ofmanufacture of claim 11, comprising: instructions for receiving, withthe processor, an indication that a third analyte monitoring device iscommunicatively coupled to the data processing device, wherein the thirdanalyte monitoring device includes a third plurality of analytemonitoring features, and wherein the third plurality of analytemonitoring features include at least one analyte monitoring feature thatis absent from the first and second plurality of analyte monitoringfeatures; instructions for determining, with the processor, a thirdplurality of application features for the third analyte monitoringdevice, wherein the third plurality of application features areassociated with the third plurality of analyte-monitoring features, andthe third plurality of application features include at least oneapplication feature that is absent from the first and second pluralityof application features; and instructions for enabling, with theprocessor, the third plurality of application features on the dataprocessing device for the third analyte monitoring device.
 20. Thearticle of manufacture of claim 19, comprising: instructions fordisabling, with the processor, application features from the firstplurality and second plurality of application features that are absentin the third plurality of application features.
 21. An analytemonitoring device, comprising: a housing; a strip port coupled to thehousing; a processor coupled to the housing; and memory operably coupledto the housing and electrically coupled to the first processor, whereinthe memory includes instructions stored therein for programming ananalyte monitoring device in advance, the instructions comprising:instructions for receiving, with a processor on an analyte monitoringdevice, programming instructions for operating the analyte monitoringdevice in a first mode beginning at a future point in time, wherein thefuture point in time is based on an occurrence of an event; instructionsfor enabling, with the processor, the operation of the analytemonitoring device in a second mode before the future point in time; andinstructions for enabling, with the processor, the operation of theanalyte monitoring device in the first mode beginning at the futurepoint in time.
 22. The analyte monitoring device of claim 21, whereinthe event is a future clinical visit.
 23. The analyte monitoring deviceof claim 22, wherein the future point in time is a predetermined amountof time before the clinical visit.
 24. The analyte monitoring device ofclaim 23, wherein the operation of the analyte monitoring device in thefirst mode is enabled for a predetermined duration of time.
 25. Theanalyte monitoring device of claim 21, wherein the operation of theanalyte monitoring device in the first mode comprises performing analytemeasurements and recording the analyte measurements, and operating theanalyte monitoring device in the second mode comprises performinganalyte measurements without recording the analyte measurements.
 26. Theanalyte monitoring device of claim 21, wherein the operation of theanalyte monitoring device in the first mode comprises operating in afirst data gathering mode, and wherein the operation of the analytemonitoring device in the second mode comprises operating in a seconddata gathering mode.
 27. The analyte monitoring device of claim 21,wherein the future point in time is a predetermined amount of timebefore the event.
 28. The analyte monitoring device of claim 21, whereinthe operation of the analyte monitoring device in the first mode isenabled for a predetermined duration of time.
 29. The analyte monitoringdevice of claim 21, wherein the operation in the first mode comprisesactivating additional user interfaces, reminders, or alarms that aredifferent than in the second mode.
 30. The analyte monitoring device ofclaim 21, wherein the analyte is glucose.
 31. The analyte monitoringdevice of claim 21, wherein the event is the programming of the analytemonitoring device.
 32. The analyte monitoring device of claim 31,wherein the future point in time is a predetermined amount of time afterthe programming of the device.
 33. The analyte monitoring device ofclaim 21, wherein the operation in the first mode and second modecomprises operating the analyte monitoring device with differentconfiguration settings.
 34. The analyte monitoring device of claim 21,wherein the programming instructions are received via the internet. 35.The analyte monitoring device of claim 21, wherein the programminginstructions are received via a remote data processing deviceoperatively coupled to the analyte monitoring device.
 36. The analytemonitoring device of claim 21, wherein the event is a future datacondition obtained by the analyte monitoring device, and the futurepoint in time is at an occurrence of the future data condition.
 37. Theanalyte monitoring device of claim 36, wherein the future data conditionis an occurrence of a measurement reading.
 38. The analyte monitoringdevice of claim 36, wherein the future data condition is a thresholdmeasurement reading.
 39. The analyte monitoring device of claim 36,wherein the future data condition is a predetermined trending magnitude.40. The analyte monitoring device of claim 36, wherein the future datacondition is an occurrence of a pattern.
 41. The analyte monitoringdevice of claim 36, wherein the future data condition is a user-enteredcondition.
 42. The analyte monitoring device of claim 36, wherein theoperation of the analyte monitoring device in the first mode comprisesperforming analyte measurements and recording the analyte measurements,and operating the analyte monitoring device in the second mode comprisesperforming analyte measurements without recording the analytemeasurements.
 43. The analyte monitoring device of claim 36, wherein theoperation of the analyte monitoring device in the first mode comprisesoperating in a first data gathering mode, and wherein the operation ofthe analyte monitoring device in the second mode comprises operating ina second data gathering mode.
 44. The analyte monitoring device of claim36, wherein the operation of the analyte monitoring device in the firstmode is enabled for a predetermined duration of time.
 45. The analytemonitoring device of claim 36, wherein operation in the first modecomprises activating additional user interfaces, reminders, or alarmsthat are different than in the second mode.
 46. The analyte monitoringdevice of claim 36, wherein the analyte is glucose.
 47. The analytemonitoring device of claim 36, wherein operation in the first mode andsecond mode comprises operating the analyte monitoring device withdifferent configuration settings.
 48. The analyte monitoring device ofclaim 36, wherein the programming instructions are received via theinternet.
 49. The analyte monitoring device of claim 36, wherein theprogramming instructions are received via a remote data processingdevice operatively coupled to the analyte monitoring device. 50.-86.(canceled)
 87. An analyte monitoring device, comprising: a housing; astrip port coupled to the housing; an output display coupled to thehousing; a processor coupled to the housing; memory operably coupled tothe housing and electrically coupled to the first processor, wherein thememory includes instructions stored therein for personalizing theanalyte monitoring device, the instructions comprising: instructions fordisplaying, with the processor, a user interface on the output display,wherein the user interface enables a user to personalize the analytemonitoring device, wherein personalizing the analyte monitoring devicecomprises configuring the analyte monitoring device to display a userselected background image; instructions for receiving input for a userselected background image; and instructions for configuring the analytemonitoring device to display the user selected background image.
 88. Theanalyte monitoring device of claim 87, wherein the background image isdisplayed during a waiting period for an analyte measurement.
 89. Theanalyte monitoring device of claim 88, wherein the analyte is glucose.90. The analyte monitoring device of claim 87, wherein the instructionscomprise: displaying, with the processor, a plurality of pre-installedbackground images on the output display, wherein the user selectedbackground image is a user selected one of the plurality ofpre-installed background images.
 91. The analyte monitoring device ofclaim 87, wherein receiving input for the user selected background imagecomprises receiving a user uploaded background image.
 92. The analytemonitoring device of claim 87, wherein the personalizing of the analytemonitoring device comprises configuring the analyte monitoring device todisplay a user selected name.
 93. The analyte monitoring device of claim87, wherein the input is entered from the analyte monitoring device. 94.The analyte monitoring device of claim 87, wherein the input is enteredfrom the remote data processing device.
 95. An analyte monitoringdevice, comprising: a housing; a strip port coupled to the housing; aoutput display coupled to the housing; a processor coupled to thehousing; memory coupled to the housing and operably coupled to theprocessor, wherein the memory includes instructions stored therein forexecution by the processor to graphically represent a remaining insulinlevel in a user body on the output display, the instructions comprising:instructions for displaying a first marker on the output display toindicate a maximum amount of insulin; instructions for displaying asecond marker on the output display to indicate a minimum amount ofinsulin; instructions for displaying a indication element on the outputdisplay to Indicate a current amount of insulin in the user body,wherein the positional relation of the indication element to the firstand second markers is approximately proportional to the percentage ofinsulin remaining in the body.
 96. The analyte monitoring device ofclaim 95, wherein the indication element is a fill-level of a graphicalelement, and wherein the second marker is at one end of the graphicalelement and corresponds to a zero percent fill-level, and wherein thefirst marker is at an opposite end of the graphical element andcorresponds to a one hundred percent fill-level.
 97. The analytemonitoring device of claim 96, wherein the graphical element is abody-shaped, and wherein the second marker is at a foot-end of thebody-shaped graphical element, and wherein the first maker is at ahead-end of the body-shaped graphical element.
 98. The analytemonitoring device of claim 95, wherein the indication element is anarrow pointing to a position at or between the first marker and thesecond marker.
 99. The analyte monitoring device of claim 95, whereinthe instructions comprise: instructions for displaying one or moreidentifying markers between the first marker and second marker torepresent divisions, approximate values, or thresholds. 100.-107.(canceled)
 108. An analyte monitoring device, comprising: a housing; astrip port coupled to the housing; a processor coupled to the housing;and memory coupled to the housing and operably coupled to the processor,wherein the memory includes instructions stored therein for execution bythe processor to control access to features of the analyte monitoringdevice, the instructions comprising: instructions for enabling a firstset of features of the analyte monitoring device; instructions forpreventing user access to a second set of features of the analytemonitoring device, wherein the second set of features becomes enabledfor user access based on an occurrence of an event; instructions forreceiving an indication of the occurrence of the event; and instructionsfor enabling the second set of features.
 109. The analyte monitoringdevice of claim 108, wherein the instructions comprise: instructions forreceiving programming instructions by an authorized user, wherein theprogramming instructions comprise instructions for defining the secondset of features and the event.
 110. The analyte monitoring device ofclaim 108, wherein the programming instructions are received by a remotedevice communicatively coupled to the analyte monitoring device. 111.The analyte monitoring device of claim 108, comprising: instructions forconfirming user qualifications to use the second set of features,wherein the event is a successful confirmation.
 112. The analytemonitoring device of claim 108, wherein the instructions for confirminguser qualification comprises instructions for presenting one or moretest questions for the user.
 113. The analyte monitoring device of claim108, wherein the second set of features comprises a bolus calculator orbasal calculator.
 114. The analyte monitoring device of claim 108,wherein the event is entry of a password or key code.
 115. The analytemonitoring device of claim 108, wherein the second set of features isbased on a user profile. 116.-126. (canceled)